Ignite Creation Date:
2024-05-05 @ 5:32 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474838
Status:
COMPLETED
Last Update Posted:
2013-09-26
First Post:
2007-05-16
Brief Title:
Study To Evaluate Beta Cell Function and Glycemic Outcome by Intensive Insulin Therapy
Sponsor:
Kyunghee University Medical Center
Organization:
Kyunghee University Medical Center
Study Overview
Official Title:
The Effect of Intensive and Short-term Insulin Treatment on Long-term Pancreatic β-cell Function in Newly Diagnosed People With Type 2 Diabetes in Korea
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
KIIT
Brief Summary:
This randomized controlled prospective study aims to evaluate the efficacy of intensive insulin therapy for long term glycemic control and improvement or preservation of beta cell function in newly diagnosed type 2 diabetes patients
Detailed Description:
Type 2 diabetes is associated with beta cell dysfunction and insulin action at diagnosis of diabetes Although the relative importance of these two alterations is controversial growing evidence is swinging to the concept that there is no hyperglycemia without β-cell dysfunction Also there is agreement that deterioration of glucose tolerance over time is associated with a progressive decrease of beta cell function
Beside the role of genetic factor the continuous decline in β-cell function is affected by glucotoxicity generated by hyperglycemia and lipotoxicity due to high fatty acid A vicious cycle of hyperglycemia per se further impairs and may destroy β-cell Recently many reports have shown that early intensive glycemic control plays a role in the prevention of progressive ß-cell function and worsening of diabetes
Some studies have shown that early intensive insulin therapyIIT to achieve near normoglycemia in new onset type 2 diabetes gives short term and long term improvement in glycemic control after discontinuation of insulin It is suggested that long term glycemic control is associated with improvement of β-cell function
In the unpublished previous pilot study the investigators found that early intensive insulin therapy using multiple daily injection MDI or daily twice injection in newly diagnosed type 2 diabetes can significantly improve the beta cell function and facilitate further long term glycemic control To establish the effectiveness of intensive insulin therapy for long term glycemic control and improvement of β-cell function the investigators will perform a randomized controlled prospective study in newly diagnosed type 2 diabetes in Korea
Beside the role of genetic factor the continuous decline in β-cell function is affected by glucotoxicity generated by hyperglycemia and lipotoxicity due to high fatty acid A vicious cycle of hyperglycemia per se further impairs and may destroy β-cell Recently many reports have shown that early intensive glycemic control plays a role in the prevention of progressive ß-cell function and worsening of diabetes
Some studies have shown that early intensive insulin therapyIIT to achieve near normoglycemia in new onset type 2 diabetes gives short term and long term improvement in glycemic control after discontinuation of insulin It is suggested that long term glycemic control is associated with improvement of β-cell function
In the unpublished previous pilot study the investigators found that early intensive insulin therapy using multiple daily injection MDI or daily twice injection in newly diagnosed type 2 diabetes can significantly improve the beta cell function and facilitate further long term glycemic control To establish the effectiveness of intensive insulin therapy for long term glycemic control and improvement of β-cell function the investigators will perform a randomized controlled prospective study in newly diagnosed type 2 diabetes in Korea
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None